Overview: This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice is, what needs to be documented, why it is documented, and FDA expectations for documentation.

The webinar explores what the GxP regulations and guidances say about Good Documentation Practice. Examples of both good and poor documentation are given and exercises demonstrate both good and poor practices.

Why you should attend: In today's strict regulatory environment it is more important than ever for companies and individuals to understand and practice good documentation to comply with FDA regulatory requirements. This webinar will cover Good Documentation Practice for GxP environments. Understand what needs to be documented, what FDA looks for in documentation, relevant regulations for documentation, and related guidances.

Areas Covered In the Session:

FDA 101: who is the FDA, regulations, guidances, documentation and me

Why document?

What needs to be documented?

What documentation does FDA look for during an inspection?

What do the GMP, GCP, and GLP regulations and guidances say about documentation?

Examples and exercises for good documentation

Summary/ Q&A

Who will benefit:

GxP personnel involved with GxP Documentation

R&D

Production

Quality

Regulatory

John currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA.

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